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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4043

2. Registrant Information.

Registrant Reference Number: Prosar 1-16620323

Registrant Name (Full Legal Name no abbreviations): Scotts Canada Ltd

Address: 2000 Argentia Road Plaza 5 Suite 101

City: Mississauga

Prov / State: Ontario

Country: Canada

Postal Code: L5N2R7

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

10-SEP-08

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

07-SEP-08

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No. 27521      PMRA Submission No.       EPA Registration No.

Product Name: Home Defense Max Perimeter/Indoor Insect Control Ready To Use (Ortho)

  • Active Ingredient(s)
    • PERMETHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

The product was sprayed by the reporter on 09/07/2008 and 09/08/2008 while wearing a mask.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Difficulty Breathing
  • Nervous and Muscular Systems
    • Symptom - Dizziness
    • Specify - "Feeling faint"
  • Respiratory System
    • Symptom - Respiratory pain
    • Symptom - Respiratory pain
    • Specify - "Inflammation of the lining around the lungs"
  • Cardiovascular System
    • Symptom - Chest pain

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Unknown

8. How did exposure occur? (Select all that apply)

Application

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Respirator

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

1-16620323: A reporter (patient) called on 09/10/2008 to report her exposure to an indoor and outdoor insecticide containing the active ingredient Permethrin. According to the reporter, she had used the product for 20 minutes on 09/07/2008 and for 20 minutes on 09/08/2008. At the time of the call, the reporter stated that she had pre-existing asthma and was diagnosed with bronchitis and sinus problems 6 weeks prior to the report. She had worn a mask and had the windows open during the product application. The reporter felt faint and had difficulty breathing at night after the product exposure and needed to use her inhaler an extra time. She did see her health care provider twice in two days and was started on Singulair and Advair. At the time of the report, the reporter was feeling better but wanted to know if she would require medications for the rest of her life. The reporter was advised that individuals who find the product's odor strong or unpleasant may develop self-limiting signs of nausea, headache, and respiratory irritation. A recommendation was made to ventilate the area and add portable fans until the odor has dissipated. A recommendation was also made to wash treated surfaces with a household cleanser and to consult her medical doctor regarding her condition and treatments. On follow up, the reporter stated that she had been feeling better while resting, but once she became active again, she developed respiratory/chest pain (under Left breast). She was evaluated in the emergency room for possible cardiac problems, but she was ultimately diagnosed with inflammation of the lining around her lungs. The reporter was treated with a dose of prednisone and was advised to take an analgesic to help with pain relief. No further information was obtained.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.